Medical device insertion apparatus, system and method

ABSTRACT

An insertion device is disclosed. The insertion device includes a base portion, a top portion slidably connected to the base portion, an introduction needle, a catheter in slidable relation to the introduction needle, and a substantially cylindrical flash chamber, the flash chamber having an inlet in fluid communication with the introduction needle. The flash chamber is connected to the base portion, the top portion slidably engages with the flash chamber, and the catheter and the top portion slidably advance with respect to the introduction needle and the base portion.

TECHNICAL FIELD

The present invention relates to medical device insertion and moreparticularly, to apparatus, system and method for medical deviceinsertion.

BACKGROUND INFORMATION

Inserting a medical device into a patient may present difficulties. Forexample, when inserting a medical device or catheter into a patient'svein, the needle may enter the vein on one side and proceed to piercethrough the opposite side, presenting an injury to the patient. Otherdifficulties exist with respect to releasing the catheter at the properposition such that the catheter is in the vein. Thus, difficulties existwhen determining the proper time to release the catheter such that it isin the vein, but before the needle pierces the opposing wall of thevein. Additional situations regarding the insertion of a catheter orother medical device present similar difficulties, thus, the insertiondifficulties are not only limited to catheters or insertion into veins.

Accordingly, there is a need for a device to aid with proper insertionof a medical device, including a catheter, into a patient that reducesthe occurrence of unintentional piercing by the introduction needle andreleasing the medical device or catheter prior to insertion into thedesired area.

SUMMARY

In accordance with one aspect of the present invention, an insertiondevice is disclosed. The insertion device includes a base portion, a topportion slidably connected to the base portion, an introduction needle,a catheter in slidable relation to the introduction needle, and asubstantially cylindrical flash chamber, the flash chamber having aninlet in fluid communication with the introduction needle. The flashchamber is connected to the base portion, the top portion slidablyengages with the flash chamber, and the catheter and the top portionslidably advance with respect to the introduction needle and the baseportion.

Some embodiments of this aspect of the present invention may include oneor more of the following, in any combination or separately: wherein theflash chamber further includes an insert; wherein the insert is acylindrical insert; and/or wherein the insert includes a colorcontrasting to the color of a flash fluid; and/or wherein the insertincludes a material having wicking properties; and/or wherein thewicking material further includes an assay test strip wherein the assaytest strip indicates the presence of one or more indicators in a fluid;and/or wherein the flash chamber further includes a filter; and/orwherein filter includes a membrane material; and/or wherein the flashchamber further includes an expandable membrane in fluid communicationwith the introduction needle; and/or wherein the insertion devicefurther includes a needle guard removably connected to the base portion;and/or wherein the top portion further includes an opening to at least aportion of the flash chamber whereby the flash chamber may be viewed;and/or wherein the device further includes a locking mechanism, whereinas the top portion advances with respect to the base portion, thelocking mechanism moves from an unlocked position to a locked position,whereby in the locked position, the top portion is positioned about theneedle; and/or wherein the catheter further includes a distal endincluding a non-perpendicular angle to the axis of the catheter and anunderside conforming to a keel of the introduction needle.

Additionally, some embodiments of any aspect of the present inventionmay include one or more of the following, in any combination orseparately, wherein the device further includes a locking mechanismhaving a first end and a second end, the locking mechanism located onthe base portion; and a clip connected to the top portion, wherein theclip adapted to accommodate and control the locking mechanism andwherein the clip slidably engages the locking mechanism, wherein as thetop portion slidably advances with respect to the base portion, the clipslidably advances from the first end of the locking mechanism to thesecond end of the mechanism, whereby the locking mechanism moves from anunlocked to a locked position and whereby in the locked position, thetop portion is positioned about the needle.

In accordance with another aspect of the present invention, an insertiondevice is disclosed. The insertion device includes a base portion, a topportion slidably connected to the base portion, a substantiallycylindrical flash chamber, the flash chamber having an inlet and adaptedfor connection to an introduction needle, wherein the top portionslidably engages with the flash chamber, and a locking mechanism,wherein as the top portion advances with respect to the base portion,the locking mechanism moves from an unlocked position to a lockedposition.

Some embodiments of this aspect of the present invention may include oneor more of the following, in any combination or separately: wherein theflash chamber further includes an insert; and/or wherein the insert is acylindrical insert.

In accordance with another aspect of the present invention, a method isdisclosed. The method includes generating 2.45 GHz Radio Frequencyenergy using a magnetron, moving a needle towards an object and acontact, maintaining a connection between the needle and the contact,generating a plasma arc, and moving the needle into contact with theobject.

Some embodiments of this aspect of the present invention may include oneor more of the following, in any combination or separately: wherein themethod further includes moving the needle into contact with a die cavityfor a predetermined amount of time and removing the needle from the diecavity; and/or wherein the method further includes moving the needleinto contact with a plastic tube, melting the plastic tube, and coolingthe plastic tube wherein the plastic tube forms a seal about the needle.

These aspects of the invention are not meant to be exclusive and otherfeatures, aspects, and advantages of the present invention will bereadily apparent to those of ordinary skill in the art when read inconjunction with the appended claims and accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reading the following detailed description, takentogether with the drawings wherein:

FIG. 1A is a view of a device according to one embodiment;

FIG. 1B is an exploded view of the device shown in FIG. 1A;

FIG. 1D is a magnified view of section “B” in FIG. 1C;

FIG. 1E is view of a clip according to one embodiment;

FIGS. 1F-1G are views of the locking mechanism in the locked andunlocked position; according to one embodiment;

FIG. 1H is a bottom view of a top portion of a device according to oneembodiment;

FIGS. 2A-2C are various partial views of the device according to oneembodiment;

FIG. 3A is a partial cross-sectional view of a standard catheter;

FIG. 3B is a partial cross-sectional view of a catheter according to oneembodiment;

FIG. 4A is a partial cross-section view of a standard catheter andintroduction needle according to one embodiment;

FIG. 4B is a partial cross-section view of a catheter and introductionneedle according to one embodiment;

FIG. 5A is a partial exploded view of the system in the unlockedposition according to one embodiment;

FIG. 5B is a magnified view of the indicated section in FIG. 5A;

FIG. 5C is a partial exploded view of the system in the locked positionaccording to one embodiment;

FIGS. 6A-6H are illustrated, sequential views of the device in practice,according to one embodiment;

FIG. 7 is a view of one embodiment of the device;

FIGS. 8A-8B are views of one embodiment of the device;

FIGS. 8C and 8D are views of one embodiment of the device;

FIG. 9A is a view of one embodiment of the device in the unlockedposition;

FIG. 9B is a view of the embodiment of the device shown in FIG. 9A inthe unlocked position;

FIG. 10A is a view of one embodiment of the device in the unlockedposition;

FIG. 10B is a view of the embodiment of the device shown in FIG. 10A inthe unlocked position;

FIG. 11A is a view of one embodiment of the device in the unlockedposition;

FIG. 11B is a view of the embodiment of the device shown in FIG. 11A inthe unlocked position;

FIG. 12 is an illustrative view of one embodiment of the rack-and-pinionembodiment of the device;

FIG. 13A is an illustrative view of one embodiment of the packaging withthe device;

FIG. 13B is an illustrative view of one embodiment of the packaging withthe device;

FIGS. 14A-14C are illustrative views of a method of making a needleaccording to one embodiment;

FIGS. 14D-14E are illustrative views of a technical problem according toone method of making needles;

FIGS. 15A-15B are views of one embodiment of a catheter;

FIGS. 15C-15E are views of one embodiment of the catheter shown in FIGS.15A-15B together with an introduction needle according to oneembodiment;

FIGS. 16A-16C are illustrative views of a method of making a needleaccording to one embodiment;

FIGS. 17A and 17B are illustrations of a magnetron and a circuitaccording to one embodiment of the method;

FIG. 18A is an illustration of one method according to one embodiment;

FIG. 18B is an illustration of one method according to one embodiment;and

FIGS. 19A and 19B are illustrative examples of one method of making aneedle according to one embodiment.

DETAILED DESCRIPTION

The device and methods include an insertion device. The device may beused to insert an object, e.g., a medical device, into a patient,whether human or otherwise. In the exemplary embodiment, the device maybe used to insert a catheter into a vein, for example, inserting an IVcatheter. However, the device may be used for other applications,including, but not limited to, other vascular access application. Thedevice may be beneficial for many reasons, including, but not limitedto, increasing the success rate of insertion of the medical device anddecreasing and/or limiting the trauma to the vessel during insertion.

In some embodiments of the device, the device includes an introductionneedle and a catheter. The introduction needle may be located inside thecatheter before the catheter is inserted into a patient. Theintroduction needle may be connected to the device, and the catheter maybe inserted over the introduction needle. In some embodiments, theintroduction needle and catheter are manufactured and packaged in anassembled fashion.

The device may be used to insert a catheter into a patient such that theintroduction needle includes an opening that would enter the veinconcurrent with or subsequent to the catheter entering the vein. Theopening may be in fluid connection with a “flash chamber” in the devicewhich allows for blood, or flash fluid, from the vein, or otherwisefluid from the area of the desired catheter destination, to flow throughthe hole in the introduction needle to the flash chamber. Thus, blood,or flash fluid, entering the flash chamber may indicate that thecatheter has entered the vein/desired location. In various embodiments,the flash chamber may be located on the device such that a user may viewthe flash chamber easily while inserting the catheter.

Although discussion regarding the use of the insertion device forinserting a catheter into a vein is used throughout this description asan exemplary embodiment, the device is not limited to use as a catheterinserter into a vein and may be used to insert a catheter into otherplaces on a patient's body. In some embodiments, the fluid visible inthe flash chamber may be blood, and in other embodiments, the fluidvisible in the flash chamber may be another bodily fluid, which mayinclude, but is not limited to, urine and spinal fluid. In addition tocatheters, in some embodiments, the device described may be used forinsertion of various medical devices, including, but not limited to,needles, RFID chips, vascular access application and analyte sensors.

Various methods of making the introduction needles, various shapes ofthe catheter as well as various embodiments of the device are describedherein. However, these are not meant to be limiting, rather, they areillustrative examples of various embodiments.

Referring first to FIGS. 1A-1B, an exemplary embodiment of an insertiondevice is shown. Various embodiments of the insertion device aredescribed herein and additional embodiments may include one or morefeatures from one or more of the various embodiments in combination,forming additional embodiments. Thus, the various embodiments andcombinations shown and described herein are not meant to be limiting,rather, examples of the multitude of embodiments.

In various embodiments of the device, the device may include a topportion 100 and a base portion 102. The top portion 100 and base portion102 may be slidably connected. In some embodiments, the top portion 100may slide over a portion of a flash member 108. In some embodiments, arelief-and-protrusion type mechanism relationship may provide thesliding mechanism for the top portion 100 with respect to the baseportion 102.

In some embodiments, the flash member 108 may be attached to the baseportion 102 and the top portion 100 may include a feature to accommodatethe shape of the flash member 108 such that the top portion 100 mayslide over the flash member 108, may be which may be connected to thebase portion 102. Referring now also to FIG. 1H, in the exemplaryembodiment, the top portion 100 is a substantially hollow cylindricalportion and may include an open area 126 to accommodate the flash member108. Additionally, in the exemplary embodiment, the top portion 100 mayinclude a window 116, which, in the exemplary embodiment, is an openingin the top portion 100 such that the flash member 108 may be visiblewhen positioned above the flash member 108. Although not shown in theexemplary embodiment, in some embodiments, the flash member 108 may beconnected or attached to the top portion 100 and another embodiment ofthe sliding mechanism may be used for the top portion 100 to slidablyadvance with respect to the base portion 102.

The top portion 100 and base portion 102 may be made from a transparentplastic material, including, but not limited to, one or more of thefollowing: polyester, acrylic and polycarbonate and for anythermoplastic. However, in some embodiments, the top portion 100 and/orbase portion 102 may be made from non-transparent materials, including,but not limited to, FEP/TPEP (TEFLON). In the exemplary embodiment, thetop portion 100 may be made transparent and the base portion 102non-transparent material. As discussed in greater detail below, theflash member 108 may be made transparent while the insertnon-transparent, or, white, in the exemplary embodiment.

Although the exemplary embodiment and various other embodiments of thedevice are described herein, the shapes and sizes of the various partsof the various embodiments are not limited to those described herein.Thus, the shapes and sizes may vary in various embodiments.

Referring now to FIGS. 2A-2C, the flash member 200 is shown with theflash chamber 202. The flash member 200 includes a connection section212 for connecting to the base member 210, in the exemplary embodiment,and a position tab 204 for maintaining the clock of the catheterassembly 214 or medical device assembly to be inserted onto the topportion (not shown, shown in FIGS. 1A-1B as 100). The flash member 200includes a flash chamber 202. In various embodiments, the introductionneedle 218 is in fluid communication with the flash chamber 202. In someembodiments, the bore of the introduction needle 218 is in fluidcommunication with the flash chamber 202. Thus, the hole/opening in theintroduction needle 218 provides the path for the flash fluid to flow tothe flash chamber 202.

In some embodiments, the flash chamber 202 may be cylindrical. In someembodiments, the flash chamber 202 may be hollow. Some embodiments ofthe flash chamber 202 include wherein the inside wall of the hollowflash chamber 108 may include, but are not limited to, one or more ofthe following features: textured, raised, grooved and/or rib-likefeatures. Some embodiments may include a flash chamber 202 that isshaped other than cylindrical, including, but not limited to, a hollowrectangular shape or a hollow square shape.

In some embodiments, the flash chamber 202 may include an insert 206. Asshown in the exemplary embodiment, the insert 206 may be cylindrical. Insome embodiments, the insert 206 may be hollow, however, in someembodiments; the insert 206 may be solid. In the exemplary embodiment,the insert is constructed of a color or a texture to provide contraststo the fluid, e.g., blood, that enters the flash chamber 202. Forexample, in the exemplary embodiment, where the fluid is blood, theinsert 206 may be white to provide contrast to the red blood. However,in some embodiments, the insert 206 may be any coloration or texture,including, but not limited to, one or more of the following features:raised, grooved and/or rib-like features, that provides sufficientcontrast such that the presence of the fluid may be easily ascertainableby a user. This may be greatly advantageous as, in many instances, whileinserting a catheter, for example, into a patient, it may be difficultto differentiate between the flash fluid and, for example, the patient'sskin/fur/hair tone or the patient's clothing. Thus, by enabling the userto readily discern the flash fluid, the user will readily cease tofurther insert the needle and insert the catheter, preventing piercingof the opposite side of the vein.

The insert 206 displaces a portion of the total volume of the flashchamber 202. in the exemplary embodiment, the insert 206 displaces aportion of the center flash chamber 202, thus, the flash fluid may bevisible through 360 degrees of the cylindrical flash chamber 202. Thus,in the exemplary embodiment, the cylindrical insert 206 provides for 360degree flash viewing in the flash chamber 202, however, the insert 206,displacing a portion of the volume of chamber, a smaller volume of flashfluid is necessary to fill the flash chamber 202, and hence, the flashfluid may be readily discerned at a faster rate. In the exemplaryembodiment, the flash fluid forms a thin layer about the flashcylindrical insert 206, which may be sufficient, as the cylindricalinsert 206 may be a contrasting color, e.g. white, compared with theflash fluid, e.g. blood.

Still referring to FIGS. 2A-2C, in the exemplary embodiment, the flashmember 200 includes a filter 208 at the end of the flash chamber 202.The filter may be a porous filter that allows air to pass and does notallow the flash fluid to pass through the filter. In variousembodiments, the porous filter may be made from one or more, but notlimited to, the following: PTFE or HDPE. In some embodiments, the porousfilter may be replaced with a membrane material, for example, one madefrom PCTW or polyester. In these embodiments, the membrane may be weldedto the end of the flash chamber 202.

In the exemplary embodiment, the flash chamber 202 is a capillary actionflash chamber 202. However, in various other embodiments, the flashchamber 202 may be a wicking action flash chamber 202. In theseembodiments, the flash chamber 202 may include an insert of wickingmaterial, or, a material having wicking properties, which may include,but is not limited to, cotton, cotton blends, hydrogels or a porouspolyethylene, or PTFE material, which may include, but is not limitedto, POREX, made by POREX Technologies, Fairburn, Ga., or another porouspolymer. In some embodiments, the wicking material insert may be coatedwith one or more coatings to ensure wicking but not dripping. In someembodiments including a flash chamber 202 applying a wicking action, avent may be used, rather than filter or membrane.

In some embodiments, the wicking material may also include an assay teststrip or an assay embedded into the wicking material that, upon contactwith the flash fluid, may indicate the presence of one or more, but notlimited to, the following: proteins, compounds (including, but notlimited to, pharmaceuticals, nutrients, controlled substances, etc),viruses, parasites, and/or elements, diseases or conditions. Forexample, the assay may indicate the presence of human chorionicgonadotropin (hCG), indicating pregnancy, and/or the presence of avirus, or parasite, for example, through a reaction of the fluid to anantibody in the wicking material. In some embodiments, by detecting thepresence of proteins, compounds, viruses, and/or parasites, this mayprevent a medical error that may cause harm to the patient, for example,administering a medication that may be harmful to a pregnant woman,and/or react with the presence of another drug already in the bloodstream, etc.

In some embodiments, the flash chamber 202 may include a membrane or bagfluidly connected to the introduction needle. In some embodiments, themembrane or bag may be made from one or more of, but not limited to, thefollowing: polyethylene, polyurethane, or other thin-film plastics orelastomers. Thus, in these embodiments, the bag may fill with flashfluid as the introduction needle enters the area for medical deviceinsertion, e.g., the vein. In these embodiments, a vent, and/or a layerof material the same or similar to the flash chamber 202 material havingat least one opening, may be used replacing the filter or membranesdiscussed above, to seal the flash chamber 202. In other embodiments ofthis embodiment, the flash chamber 202 may not include a vent or filter.

Still referring to FIGS. 2A-2C, the flash member 200 may, in someembodiment, include an position tab 204 for maintaining the position orclock of the catheter assembly 214. In some embodiments, the catheterassembly 214 may include a groove 216 or other like feature wherein theposition tab 204 fits in a tongue-and-groove arrangement. Thus, thecatheter assembly 214 clock position is maintained by the position tab204 preventing the twisting of the catheter assembly 214 with respect tothe device to maintain correct placement for insertion. As discussed inmore detail below, in some embodiments, it is desirable to maintain thespace over the opening in the introduction needle such that the flashfluid may flow to the flash chamber 202. As such, were the catheterassembly 214 to move to another position, the opening in theintroduction needle may be occluded and as such, the flash fluid may notflow to the flash chamber 202 as quickly as it might. Thus, the positiontab 214 maintains the device such that optimal usage of the device maybe employed. Although a groove 216 is shown, in some embodiments, where,for example, the catheter assembly 214 includes a threaded portion, thegroove may be created by a space formed by the raised threaded portion.In other embodiments, various features may be introduced to the catheterassembly 214 to interact with the position tab 204 and maintain theposition of the catheter assembly 214. Various other embodiments mayinclude a different mechanism than those presented herein formaintaining the clock of the catheter with respect to the device.

The flash member 200, in the exemplary embodiment, is made from plastic,which materials may include, but are not limited to, one or more of thefollowing, alone or in combination: polyester, acrylic and polycarbonateand/or any thermoplastic. In the exemplary embodiments, the flash member200 is made from transparent material. As shown in FIG. 2C, the flashmember 200 may be adhered to the base member 210 by way of theconnection section 212. In other embodiments, where the flash member 200is not transparent, the flash member 200 may be made from FEP/TPEP(TEFLON), or any of the other materials discussed above.

An introduction needle 210 may be attached to the flash chamber 202 andmay provide a fluid connection between the introduction needle 210 andthe inside of the flash chamber 202. In some embodiments, theintroduction needle may be made from 304 or 306 stainless steel,however, in other embodiments; the introduction needle may be made fromany material desired including, but not limited to, a different gradestainless steel, polycarbonate or plastic. In the exemplary embodiment,the introduction needle is 2 inches long and may be a 20 gauge needle.However, in other embodiments, the length of the introduction needle 210and the gauge may be greater or less than the values described hereinand may depend on one or more of but not limited to, the following: themedical device, the location of insertion and the patient.

Referring now to FIGS. 1A-1H, in some embodiments, the top portion 100and/or the base portion 102, may include raised, ribbed or otherwisetextured features 118 to assist, for example, in maintaining a steadygrip on the device. Additionally, in some embodiments, the top portion100 may include a thumb feature 120 which may assist in pushing the topportion 100 forward with respect to the base portion 102 so as toadvance the top portion 100. In the exemplary embodiment, the features118 may be as shown which may be desirable to accommodate differentstyle/methods of gripping by the user and/or left handed or right-handedusers.

A catheter assembly 104 may be removably attached to the end 124 of thetop portion 100 of the device. As discussed above, in some embodiments,a mechanism for maintaining the clock or position of the catheter withrespect to the device is used. In some embodiments, this mechanism mayinclude a tongue and groove mechanism, i.e., a position tab 110 on theflash member 108 and a groove 122 on the catheter assembly 104. In theexemplary embodiment, the catheter assembly 104 is simply placed ontothe end 124 of the top portion 100, without further connection, and theclock of the catheter assembly 104 maintained by the position tab 110together with the groove 122. However, in other embodiments, thecatheter assembly 104 may be removably attached to the top portion 100,and in some embodiment, the catheter assembly 104 may removably snap fitor otherwise connect to the top portion 100, however, in theseembodiments, the user is able to release the catheter assembly 104 whendesired.

The bottom of the top portion 100 is shown (see FIG. 1H). In theexemplary embodiment, the top portion 100 includes an open area 126 toaccommodate the flash member 108 such that the top portion 100 slidablyengages with the flash member 108. As discussed above, other mechanismsmay be used to establish a sliding relationship between the top portion100 and the base portion 102 and thus, the bottom of the top portion 100may vary accordingly in other embodiments to accommodate the varioussliding mechanisms. In the exemplary embodiment, the top portion 100slides forward with respect to the base portion 102, and the open area126 slides along the flash member 108, until the end of the top portion100 is positioned at the back of the flash member 108. In the exemplaryembodiment, the travel distance is sufficient such that the top portion100 essentially reaches the end of the introduction needle 106. However,the distance traveled may vary in various embodiments. In someembodiments, the distance traveled by the top portion 100 may bedependent on at least, but not limited to, one or more of the following:length of the introduction needle 106, size of the flash member 108,length of the top portion 100.

In the exemplary embodiment, the device includes a locking mechanismwhereby the top portion 100, having traveled the full distance withrespect to the base portion 102, will release a locking mechanism tomaintain the device in a locked position, such that the top portion 100is locked into the fully traveled distance with respect to the baseportion 102. In this position, in the exemplary embodiment, the topportion 100 is locked in a position and the introduction needle 106 isessentially inside the hollow cylindrical top portion 100. This may bedesirable to essentially provide a “sharps container” for theintroduction needle 106 such that the introduction needle 106 isprotected by the top portion 100 when the device is in the lockedposition.

In the exemplary embodiment, the locking mechanism 114 includes anunlocked position, whereby the top portion 100 may slide, and in theexemplary embodiment, the top portion 100 may slide along the flashmember 108, until reaching the full travel distance, which, in theexemplary embodiment, is at the far end of the flash member 108. Thelocking mechanism also includes a locked position, whereby the topportion 100 may no longer slide with respect to the base portion 102,and is locked in place.

Still referring to FIGS. 1A-1H, and more specifically to FIGS. 1C-1H, inthe exemplary embodiment, the locking mechanism 114 includes a firstend, towards the far end of the base portion 102, and a second end,towards the near end of the base portion 102, wherein the near end isthe end closest to the introduction needle 106 in the exemplaryembodiment. In the exemplary embodiment, a clip 112, which is located ina groove 128 in the top portion 100, accommodates the locking mechanism114, such that the clip 112 slides along the locking mechanism 114 asthe top portion 100 advances with respect to the base portion 102. Theclip 112 controls the locking mechanism 114 in that the clip 112maintains the locking mechanism 114 in an unlocked position while thetop portion 100 is advancing by sliding onward with respect to the baseportion 102. At the point where the top portion 100 has reached the fulldistance of travel, the clip 112 is at a position no longer interactingwith the locking mechanism 114 and at this position; the lockingmechanism 114 is in a locked position. In the exemplary embodiment, oncethe locking mechanism 114 is in the locked position, the top portion 100is locked in the full distance position and thus, in the exemplaryembodiment, is locked over the introduction needle 106.

Although an exemplary embodiment of the locking mechanism is describedherein, other embodiments may be implemented to accomplish a similarresult, namely, locking the top portion 100 with respect to the baseportion 102 once the top portion 100 reaches a predetermined locationwith respect to the base portion 102. Although in the exemplaryembodiment, the predetermined location is when the far side of the topportion 100 reaches the far side of the flash member 108, in otherembodiment, the full distance or predetermined location may vary and thedesign of the locking mechanism may vary accordingly.

In the exemplary embodiment, the device may be used to insert a catheterinto a vein of a patient. Referring now to FIG. 3A, a cross section ofthe distal end (with respect to an insertion device) of a standardcatheter is shown. The standard catheter is a plastic tube structure andprovides a symmetrical cross-section.

Referring now to FIG. 3B, a cross section of the distal end (withrespect to an insertion device) of a catheter according to the exemplaryembodiment is shown. The distal end of the exemplary embodiment of thecatheter includes an angled cut, other than perpendicular to the axis ofthe catheter, thus, the cut is non-perpendicular angle to the axis ofthe catheter. Additionally, a section of the distal end of the catheterincludes a shape conforming to a keel of the instruction needle 106(shown in FIG. 4B as 402).

Referring now to FIGS. 4A and 4B, cross sectional drawings of twoembodiments of a catheter and introduction needle assembly are shown.Referring first to FIG. 4A, a catheter similar to the catheter shown inFIG. 3A is shown together with an introduction needle 408. The needleopening 410 is shown at the front side distal end of the needle. Inpractice, an assembly such as this may function to provide flash fluidas the front side distal end opening 410 of the needle 408 enters thevein, the flash fluid may be visible in a flash chamber before thecatheter 406 enters the vein. Thus, a user, upon seeing the flash fluid,may assume the catheter 406 has entered the vein, when in fact, it ispossible the catheter 406 has not entered the vein. As such, the usermay remove the needle 408 from the vein and find the catheter 406 is notin the vein. In other instances, as the user may attempt to avoid theunsuccessful insertion as described above, the user may overcompensateand insert the needle 408 deeper into the vein, risking piercing theopposite side of the vein.

Referring now to FIG. 4B, an exemplary embodiment of the catheter 400and introduction needle 402 assembly is shown. In this embodiment, thecatheter 400 is similar to the catheter shown in FIG. 3B. The needle 402has a keel portion underside section at the distal end of the needle402. The keel portion may be beneficial to improve the ease ofinsertion, e.g., into a vein, and may reduce the risk of unintentionalopposite wall piercing. The needle opening 404 is located on the topside of the needle and the distal end of the catheter 400 is located onthe horizontal axis with the needle opening 404. Additionally, thecatheter 400 is shaped such that it conforms to the keel portion of theunderside distal portion of the needle 402. The angular cut beingnon-perpendicular to the axis of the catheter has many advantagesincluding, but not limited to the following wherein the exemplaryembodiment cut: provides that the catheter 400 to conform to the keelportion of the needle 402; provides the needle opening 404 to beunobstructed by the catheter 400; and provides a higher incidence ofsuccessful insertion whereas when the flash fluid flows to the flashchamber, the catheter 400, being horizontally aligned with the needleopening 404, is at least partially inserted, e.g., has entered the vein.Thus, the exemplary embodiment, shown in FIG. 4B, of the catheter 400and introduction needle 402 assembly may provide for greater rates ofinsertion success.

As discussed above, and referring also to FIGS. 2A-2C, the flash member200 may, in some embodiment, include a position tab 204 for maintainingthe position or clock of the catheter assembly 214. In some embodiments,the catheter assembly 214 may include a groove 216 or other like featurewherein the position tab 204 fits in a tongue-and-groove arrangement.Thus, the catheter assembly 214 clock position is maintained by theposition tab 204 preventing the twisting of the catheter assembly 214with respect to the device to maintain correct placement for insertion.With respect to the embodiment of the catheter and introduction needleassembly shown in FIG. 4B and described above, it is desirable tomaintain the needle opening 404 such that the flash fluid may flow tothe flash chamber 202. As such, were the catheter assembly 214 (or 400in FIG. 4B) to rotate to another position, the opening 404 in theintroduction needle 402 may be occluded and as such, the flash fluid maynot flow to the flash chamber 202 as quickly as it might. Thus, theposition tab 214 maintains the device such that optimal usage of thedevice may be employed. As discussed above, various embodiments mayinclude a different mechanism than those presented herein formaintaining the clock of the catheter with respect to the device.

In the exemplary embodiment, the catheter may be an 18 gauge catheter,however, in various other embodiments, the gauge of the catheter may bea greater or lower gauge. In the exemplary embodiment, the catheter maybe 1.16 inches long, however, in other embodiments; the catheter may belonger or shorter.

Referring now to FIGS. 5A-5C, a system for inserting a medical device isshown. In this embodiment, the system includes the exemplary embodimentof the insertion device 502, described above, as well as a protectivesheath 504. As shown in FIG. 5A, the device 502 is in an unlocked andstarting position. The top portion 506 and base portion 508 are alignedone to another and the catheter assembly 510 (including both theintroduction needle and the catheter) is connected to the device, thecatheter removably connected to the top portion 506 and the introductionneedle connected to the flash member (not shown). The protective sheath504 is shown unattached to the device 502, however, in the exemplaryembodiment, the device 502, prior to use, may include the protectivesheath 504 attached to the device 502. In the exemplary embodiment, theprotective sheath 504 includes a pull tab 512, a catheter assembly guard514, and a connective portion 516, connected to both the pull tab 512and the catheter assembly guard 514. The catheter assembly guard 514aids in many ways including, but not limited to, maintaining theintegrity of the catheter assembly 510 prior to insertion into a patientand preventing unintentional needle sticks and packaging damage (wherenon-rigid embodiments of the packaging is used). In the exemplaryembodiment, the connective portion 516 includes spring-like connectiveproperties such that the protective sheath 504 may be removed byapplying force to the pull tab 512. In the exemplary embodiment, thecatheter assembly guard 514 includes a portion to protect at least aportion of the circumference of the catheter assembly 510 and at least aportion to protect the entire circumference of the distal end of thecatheter assembly 510. However, in some embodiments, the protectivesheath 504 may protect the entire circumference of the entire catheterassembly 510 and in still other embodiments, at least a portion, and insome embodiments, less than 100 percent, of the distal end of thecatheter assembly 510 may be protected. Some embodiments of the systemmay not include a protective sheath. In some embodiments, a rigidpackaging may be used to protect and maintain the integrity of thecatheter assembly. Some embodiments of rigid packaging are describedbelow with respect to FIGS. 13A-13B.

Referring now to FIG. 5B, a magnified sectional view of the distalportion of the catheter is shown. In the exemplary embodiment, thecatheter may be a catheter similar to those shown and described abovewith respect to FIGS. 3B and 4B. Referring again to FIG. 5A, the device500 includes the position tab 520 to maintain the position of thecatheter 518 with respect to the introduction needle.

Referring to FIG. 5C, the device 502 is shown in the locked position,the top portion 506 having traveled the full distance. The lockingmechanism 522 is shown and is in the locked position, having beenreleased when the clip 524 reached the back of the flash member as thetop portion 506 reached the full distance of travel with respect to thebase portion 508. In this figure, the introduction needle is not shownas it is masked by the top portion 506. In this position, the topportion 506 provides protection from for the sharp introduction needleto prevent unintentional puncturing or piercing by the introductionneedle. The catheter 518 has been removed from the top portion 506 ofthe device, and in practice, the catheter 518 would be removed after itis positioned in the patient.

In the exemplary embodiment shown in FIGS. 5A-5C, when in a fullyassembled unlocked position, i.e., similar to that shown in FIG. 5A withthe protective sheath 504 attached to the device 502, the device maymeasure about 4.512 inches in length. The distance between the top edgeof the catheter assembly guard 514 and the top edge of the pull tab 512may measure about 0.901 inches. The width of the fully assembled deviceat the point of attachment of the protective sheath 504 on the baseportion 508 may measure about 0.385 inches. In the exemplary embodiment,the angle formed between the top edge of the catheter assembly guard 514and the sheath portion between the catheter assembly guard 514 and thepull tab 512 may be about 19 degree. These measurements are approximateand serve only as example of an exemplary embodiment. Variousembodiments may include various measurements that may be greater or lessthan those given above.

Referring now to FIGS. 6A-6F, in practice, the device 600 may be used toinsert a catheter 614 into a vein 618 of a patient. FIGS. 6A-6F presenta step-by-step illustration of the system, methods and apparatus of theexemplary embodiment. Referring first to FIG. 6A, the device 600 is inthe unlocked and starting position. The catheter 614 is outside of thevein 618 and the patient's skin 626. The introduction needle 616 isinside the catheter 614. The position tab 624 maintains the catheter 614in the ideal clock position with respect to the needle 616. The flashchamber 612 is empty and the window 620 is positioned above the flashchamber 612. Referring now to FIG. 6B, the device 600, still in thelocked position, progresses towards and into the patient's skin 626.Referring now to FIG. 6C, the catheter 614 and introduction needle 616enter the vein 618, and the blood, or flash fluid, flows to the flashchamber 612, which is visible to the user through the window 620 on thetop portion 602. At this point, the user may cease to advance the device600 further towards the patient's skin 626, as advancing the entiredevice 600 advances the introduction needle further into the vein 618,which may be unnecessary as the catheter 614 has already entered thevein 618.

Thus, once the catheter 614 is in the vein 618, this may be confirmed byvisible flash fluid in the flash chamber 612, seen through the window620. At this time, to further advance the catheter 614, without furtheradvancing the introduction needle 616, which, as discussed above, isunnecessary and may cause trauma to the vessel, the user, gripping thedevice 600 and, in some embodiments, using the thumb feature 622 on thetop portion 602, which may provide for increased stability and controlof the device 600, the user advances the top portion 602 toward thepatient's skin 626, by sliding the top portion 602 with respect to thebase portion 604.

Referring to FIG. 6D, the top portion 602 has advanced towards thepatient's skin, and the catheter 614 has further advanced into the vein618. Also, the clip 610, on the top portion 602, is progressing alongthe locking mechanism 608, part of the base portion 604.

Referring to FIG. 6E, as the top portion 602 further advances towardsthe patient's skin 626, the top portion 602 is encapsulating additionalportions of the introduction needle 616. Also, the catheter 614 is beingfurther inserted into the vein 618. Referring now to FIGS. 6F-6G, thetop portion 602 advances until the top portion 602 reaches the fulldistance. At this point, the catheter 614 is fully inserted into thevein 618, the introduction needle 616 is fully encapsulated by the topportion 602 and the clip 610 releases the locking mechanism 608 and thedevice 600 is in the locked position. In the exemplary embodiment, inthe locked position, the clip 610 is located between the flash chamber612 and the locking mechanism 608. The position of the locking mechanism608 prevents the top portion 602 from sliding backwards. Thus, the topportion 602 being locked in position; the top portion 602 provides asecure container for the introduction needle 616. Referring now to FIG.6H, as discussed above, in the exemplary embodiment, the catheter 614 isremovably attached to the top portion 602. Once the catheter 614 hasbeen successfully inserted into the vein 618, by moving the device awayfrom the patient's skin, the catheter 614 may easily become separatefrom the device 600.

Although an exemplary embodiment of the device has been describedherein, various other embodiments of the device may include one or morefeatures described herein with respect to the exemplary embodiment,however, the device may include additional feature and/or includealternate embodiments of one or more features described above withrespect to the exemplary embodiment. Referring to FIG. 7, anotherembodiment of the insertion device 700 is shown. One or more contouringfeatures of the device 700 may be used in various embodiments of theexemplary embodiment. For example, in some embodiments, it may bedesirable to include one or more of the following features: a depressedthumb feature 702, one or more side cut features 704, and rib structures706, or a raised centered rib feature along at least part of the lengthof the top portion 712, such as those shown on the device 700.

Referring now to FIGS. 8A-8D, another embodiment of the insertion deviceis shown. In this embodiment, the top portion 802 includes a thumbfeature 810 and the base portion 804 includes ergonomic finger contoursfor gripping the device. In this embodiment, the flash chamber 806slides together with the introduction needle 812 into the device 800. Inthis embodiment, the thumb feature 810 may be used to advance thecatheter 808 off the introduction needle 812 when the user sees theflash fluid in the flash chamber 806. The flash chamber 806 may bevisible through a transparent feature or an opening (not shown) in thetop portion 802

Referring now to FIGS. 9A and 9B, another embodiment of the insertiondevice is shown. Referring first to FIG. 9A, the device 900 is in anunlocked position. The top portion 902 includes a thumb feature 910which includes, in this embodiment, a series of ridges along thesurface. As discussed above, the top portion and base portion mayinclude one or more features to assist the user, for example, thefeatures may increase the gripping, stability, and for comfort, of theuser. However, additional features may be used and may assist the userin one or more ways, including, but not limited to, the traits discussedherein. The flash chamber 906 (not visible but inside the feature 906)may be visible through a transparent feature or an opening (not shown)in the top portion 902. The flash chamber 906 is connected to the baseportion 904. The flash chamber 906 includes a travel stop 914 and alocking mechanism 912. The top portion 902 slides forward with respectto the base portion 904 using a relief-and-protrusion type mechanism.The flash chamber 906 remains in position. The top portion 902 travelsto full distance when the travel stop feature 908 on the top portion 902reaches the travel stop feature 914 of the base portion 904. The lockingmechanism 912 prevents the top portion 902 from sliding towards thestart position. Referring to FIG. 9B, the device 900 is shown in thelocked position. Although not shown in FIGS. 9A and 9B, an introductionneedle may attach to the flash chamber 906 through opening 916. In thelocked position, the device 900 fully encapsulates the introductionneedle as the introduction needle will be inside the top portion 902.

In the embodiment shown in FIGS. 9A-9B, the top portion 902 and theflash chamber 906 are a square or rectangular shape. In this embodiment,the base portion 904 includes ergonomic finger contours for gripping thedevice 900. The various embodiments of the device described herein arenot limited to the shapes shown in any one embodiment, features andshapes from one embodiment shown may be combined with one or morefeatures and shapes from one or more embodiments shown to create anotherembodiment.

Referring now to FIGS. 10A and 10B another embodiment of the insertiondevice is shown. Referring first to FIG. 10A, the device 1000 is in anunlocked position. The top portion 1002 includes a series of ridgesalong the surface. As discussed above, the top portion 1002 and/or thebase portion may include one or more features to assist the user, forexample, the features may increase the gripping, stability, and/orcomfort, of the user. However, additional features may be used and mayassist the user in one or more ways, including, but not limited to, thetraits discussed herein. The flash chamber 1006 (not visible but insidethe feature 1006) may be visible through a transparent feature or anopening (not shown) in the top portion 1002. The flash chamber 1006 isconnected to the top portion 1002. The flash chamber 1006 includes atravel stop 1014 and a locking mechanism 1012. The embodiment shown inFIGS. 10A and 10B is essentially an inverted version of the embodimentshown in FIGS. 9A and 9B, wherein the travel stop features 1014, 1008are located on the bottom of the flash chamber 1006, rather than on thetop, as shown in FIGS. 9A and 9B. Additionally, the flash chamber 1006is connected to the top portion 1002 in the embodiment shown in FIGS.10A and 10B, rather than the base portion, as is the case in theembodiment shown in FIGS. 9A and 9B (device 900).

Still referring to FIGS. 10A and 10B, the top portion 1002, togetherwith the flash chamber 1006, slides backward with respect to the baseportion 1004 using a relief-and-protrusion type mechanism. The topportion 1002 travels to full distance when the travel stop feature 1014on the top portion 1002 reaches the travel stop feature 1008 of the baseportion 1004. The locking mechanism 1012 prevents the top portion 1002from sliding towards the start position. Referring to FIG. 10B, thedevice 1000 is shown in the locked position. Although not shown in FIGS.10A and 10B, an introduction needle may attach to the flash chamber 1006through opening 1016. In the locked position, the device 1000 fullyencapsulates the introduction needle as the introduction needle will beinside the top portion 1002.

In the embodiment shown in FIGS. 9A-9B, the top portion 902 and theflash chamber 906 are a square or rectangular shape. In this embodiment,the base portion 904 includes ergonomic finger contours for gripping thedevice 900. The various embodiments of the device described herein arenot limited to the shapes shown in any one embodiment, features andshapes from one embodiment shown may be combined with one or morefeatures and shapes from one or more embodiments shown to create anotherembodiment.

Referring now to FIGS. 11A and 11B, another embodiment of the insertiondevice is shown. Referring first to FIG. 11A, the device 1000 is in anunlocked position. The top portion 1102 includes a series of ridgesalong the surface. As discussed above, the top portion 1102 and/or thebase portion may include one or more features to assist the user, forexample, the features may increase the gripping, stability, and/orcomfort, of the user. However, additional features may be used and mayassist the user in one or more ways, including, but not limited to, thetraits discussed herein. In the embodiments shown in FIGS. 11A and 11B,the top portion 1102 is cropped as compared with the top portion 1002shown in FIGS. 10A and 10B. In some embodiments, it may be desirable tohave a shorter length top portion 1002 (or bottom portion). In theembodiment shown in FIGS. 11A and 11B, the length of the top portion1102 may reduce the total weight of the device and may require lessmaterial to manufacture, both of which may be desirable and/oradvantageous.

The flash chamber 1106 (not visible but inside the feature 1106) may bevisible through a transparent feature or an opening (not shown) in thetop portion 1102. The flash chamber 1106 is connected to the top portion1102. The flash chamber 1106 includes a travel stop 1014 and a lockingmechanism 1012. The embodiment shown in FIGS. 11A and 11B is similar tothe embodiment shown in FIGS. 10A and 10B, wherein the travel stopfeatures 1114, 1108 are located on the bottom of the flash chamber 1106,rather than on the top, as shown in FIGS. 9A and 9B. Additionally, theflash chamber 1106 is connected to the top portion 1102 in theembodiment shown in FIGS. 11A and 11B, rather than the base portion, asis the case in the embodiment shown in FIGS. 9A and 9B (device 900).

Still referring to FIGS. 11A and 11B, the top portion 1102, togetherwith the flash chamber 1106, slides backward with respect to the baseportion 1104 using a t relief-and-protrusion type mechanism. The topportion 1102 travels to full distance when the travel stop feature 1114on the top portion 1102 reaches the travel stop feature 1108 of the baseportion 1104. The locking mechanism 1112 prevents the top portion 1102from sliding towards the start position. The locking mechanism 1112 inFIGS. 11A and 11B is located on the side of the flash chamber 1106rather than the bottom or top of the flash chamber, as shown in theembodiments shown in FIGS. 9A-10B. Referring to FIG. 11B, the device1100 is shown in the locked position. Although not shown in FIGS. 11Aand 11B, an introduction needle may attach to the flash chamber 1106through opening 1116. In the locked position, the device 1100 fullyencapsulates the introduction needle as the introduction needle will beinside the top portion 1102.

With respect to the embodiments shown in FIGS. 10A-11B, the geometry ofthe base portion 1004, 1104 may be altered to accommodate all sides ofthe introduction needle (not shown) when in the locked position (seeFIGS. 10B and 11B). Alternations may include, but are not limited to,additional length added to the base portion 1004, 1104, and includingadditional geometries in the base portion 1004, 1104 structure.

Referring now to FIG. 12, in some embodiments, it may be desirable toinsert a catheter, introduction needle or other medical device that maybe longer than the travel distance of a typical user's thumb. Forexample, the various embodiments of the device described herein may beoptimal for insertion of a medical device where the total traveldistance of the medical device is equal to or less than the potentialdistance a user's thumb may slide the top portion of the insertiondevice. However, in embodiments where this is not the case, arack-and-pinion mechanism may be used to extend the total distancetraveled by the medical device. An example of a rack-and-pinionembodiment is shown in FIG. 12. In this embodiment, the total distancetraveled by the device is a function of the φ_(y)/φ_(x).

Referring now to FIG. 13A, one embodiment of rigid packaging for theembodiments of the device 1300 is shown. The packaging may include arigid portion 1302, which may be made from plastic, metal or anymaterial rigid enough to maintain the integrity of the introductionneedle and catheter assembly 1306 and preventing sharps injuries, as inthe exemplary embodiment, or, to maintain the integrity of the medicaldevice assembly for insertion, in various other embodiments. Thepackaging may be sized and shaped to accommodate the device 1300 suchthat the device withstands regular shipment, packaging, storage andusage. In some embodiments, the packaging may be generally orsubstantially cylindrical, and in some embodiments, the rigid portion ofthe packaging may include contours to best accommodate the device 1300.In some embodiments, the packaging may be vacuum formed. In someembodiments, the device 1300 may be placed inside the packaging and thepackage may be sealed 1304 with lid stock which may be made from TYVEKor material similar to TYVEK membrane. The package may then besterilized.

Referring now to FIG. 13B, in some embodiments, the packaging, asdescribed above with respect to the packaging embodiment shown in FIG.13A, may be shaped in any way desirable and, may be a vacuum formedtray-like packaging having a rigid portion 1302 and a non-rigid lid1304, which may be made from lid stock which may be made from TYVEK ormaterial similar to TYVEK membrane. The package may then be sterilized.

Referring to FIGS. 13A-13B, in use, the lid 1304 would be peeled awayfrom the rigid portion of the packaging 1302. The device 1300 may beremoved from the packaging.

Needle Formation

As described above, in some embodiments, a needle having tip or distalend wherein the distal end includes underside keel and a needle on thetop side of the distal end. Various embodiments are described herein forforming or manufacturing the needle. However, additional variations onthese embodiments may be used as well as various methods of manufacturethat would be apparent from this disclosure.

In one embodiment, a mold made from graphite, may be used. The moldwould include the intended shape of the distal end of the needle. Usingstainless steel tubing stock, and the graphite mold, the distal ends maybe weld-formed to the desired shape. Following, the distal end may beground or machined into a sharp needle.

Referring now to FIGS. 14A-14C, in another embodiment, the needletip/distal end may be formed by first using a swaging process thatcold-forms, using a series of folds, the distal end of a stainless steeltube to form a needle tip. The result of this step is shown in FIG. 14A.Next, a stamping step may be used to pre-dent the swaged shape. Theresult of this step is shown in FIG. 14B. In this step, the top of theneedle is depressed. Finally, a grinding step is used to form the needleopening/hole in the desired location. The result of this step is shownin FIG. 14C. This embodiment grinds the needle tip after a stamping stepto pre-dent the swaged shape. This embodiment may have the advantage ofreducing the risk of producing an unintended opening in the needle tipwhile grinding the needle tip following the swaging step. Grinding thetip after the stamping step to pre-dent the needle tip before grindingmay reduce the risk of unintended openings in the needle tip. Referringto FIG. 14D-14E, an example of the needle tip following the swaging stepis shown (FIG. 14D) as is an example of an unintended opening beingformed on the needle tip where the needle tip (FIG. 14E) is groundfollowing swaging, without the added step of stamping the needle tipfollowing the swaging step.

Referring now to FIGS. 15A-15E, in another embodiment of making thecatheter assembly, a standard point hypodermic needle 1504 is used asthe introduction needle. In some embodiments, as a first step, acatheter 1500 is formed, for example, in some embodiments, having theproperties described above with respect to FIGS. 3A-3B, however, inother embodiments, the catheter tip may differ. As a second step, a keel1502 is added to the catheter 1500 tip such that the keel 1502 is addedto the underside of the catheter 1500 tip. The keel 1502 essentiallyblocks the standard point hypodermic needle 1504 opening. However, insome embodiments, the standard point hypodermic needle 1504 opening maybe sealed/plugged/filled and/or blocked with an epoxy, or othermaterial, including, but not limited to, stainless steel or anothermetal, in which case welding may be used to attach the fill material. Inembodiments where an epoxy is used, the epoxy may be applied into thehole, however, in some embodiments; an additional hole may be formed onthe needle to mechanically hold the epoxy in the needle. However, insome embodiments, a catheter 1500 having a tip as shown in FIGS. 15A-15Emay be formed as a single catheter using a molding or other process formanufacture.

In the exemplary embodiment, a new needle opening 1504 is added to thestandard point hypodermic needle 1504 to serve as the needle opening influid communication with a flash chamber, for example, as discussedabove. In the exemplary embodiment, the standard point hypodermic needle1504 may be any standard point hypodermic needle available, including,but not limited to, the PRECISIONGLIDE by Becton Dickenson, FranklinLakes, N.J., U.S.A., and may be selected based on the gauge and lengthdesired for the introduction needle. In one embodiment, the standardHowever, in some embodiments, a needle may be manufactured to havesimilar characteristics to a standard point hypodermic needle, only theneedle opening may be in the desired location for fluid communicationwith the flash chamber.

In another embodiment, starting with a standard point hypodermic needle,for example, any standard point hypodermic needle available and may beselected based on the gauge and length desired for the introductionneedle, which may include the PRECISIONGLIDE by Becton Dickenson,Franklin Lakes, N.J., U.S.A., a keel may be added to the needle on theunderside, which would block/plug and/or fill the standard pointhypodermic needle opening. A new needle opening is then added to the topside of the needle, similar to the methods described above. The keel ofthe needle may be added using stainless steel or another material andmay be connected to the needle by welding. However, in otherembodiments, the keel may be formed using an epoxy. In those embodimentswhere an epoxy is used, an additional hole may be formed on the needleto mechanically hold the epoxy in the needle.

Referring now to FIGS. 16A-16C and FIGS. 17A-17B, in variousembodiments, the needle may be formed from a metal tube 1600, including,but not limited to, stainless steel, and the tip 1610 may be formedusing a die 1608. In the exemplary embodiment that follows, the tube1600 is heated to the desired temperature for molding using RadioFrequency (“RF”) energy. In the exemplary embodiment, as describedbelow, use of RF energy at a frequency of 2.45 GHz is described.However, in various other embodiments, other RF frequencies may be used,including, but not limited to, 27.10 MHz. In the various embodiments,the source of the RF energy may vary. Additionally, where the RFfrequency varies, the resonant tank circuit will vary accordingly.

In some embodiments, the RF energy may be produced by a magnetron,producing RF waves at a frequency of 2.45 GHz. In the exemplaryembodiment, the die cavity 1608 is formed in a metal block 1602, whichmay be any type of steel or another metal appropriately used as a die toform the needle tip. A spring-like assembly 1604, which may be made fromberyllium copper, or any other metal, is included and maintains contactwith the tube 1600 as the tube approaches the die cavity 1608. Althoughdescribed herein in the exemplary embodiment as being “spring-like”,other methods may be used to maintain the contact of the assembly 1604with the tube 1600. The die block 1602, spring-like assembly 1604 andthe tube 1600 together create the inductor of the circuit as illustratedin FIG. 17B. The air gap distance 1606 is the capacitor of the circuitas illustrated in FIG. 17B, and is formed between the tube 1600 and thedie cavity 1608.

To achieve a resonance of 2.45 GHz in the circuit (i.e., a resonant tankcircuit), the appropriate capacitance must be achieved against theinductance. As the inductance is fixed, the capacitance is a function ofthe distance 1606 between the tube 1600 and the die cavity 1608. Thedistance may be different for different realizations of the mechanicalconfiguration.

In the exemplary embodiment, a magnetron may be used to provide energyat 2.45 GHz into a waveguide. The assembly as described above is incommunication with the waveguide such that the assembly is heated by the2.45 GHz energy (see FIG. 17A).

As shown in FIG. 16A, as the tube 1600 approaches the die cavity 1608,the tube 1600 contacts the spring-like assembly 1604 and the distance1606 decreases. At a distance 1606, the resonant tank circuit isachieved. As the distance 1606 reaches the necessary capacitance, theplasma arc is formed. After the tip 1610 is exposed to the plasma arcfor an appropriate amount of time, the plasma arc melts the tip 1610 ofthe tube 1600. At the proper time, e.g., when the metal is at theappropriate temperature to enter the die cavity 1608, the tip 1610enters the die cavity 1608, as shown in FIG. 16B. The tip 1610 remainsin the die cavity 1608 for an appropriate time to form the desired tipshape. After the appropriate time passes, the tube 1600 is removed fromthe die cavity 1608, and as illustrated in FIG. 16C, the tip 1612 hasbeen formed by the die cavity 1608. The tube 1600 may then be removedfrom communication with the waveguide.

The methods described above may be implemented in various embodimentsfor manufacture including but not limited to, high volume manufacture,where any number of needles, for example, but not limited to, 1-100,000,for example, needles are manufactured simultaneously. With respect tothe embodiments described herein, therefore, although the descriptiondiscusses a singular tube, die cavity, etc., this is not intended to belimited, rather, be an illustration of one embodiment. Multiples of oneor more of the elements discussed may be used in the manufacture of 1 ormore needles.

In some embodiments, for example, the die cavity 1608 may be flush withthe inside of the waveguide which is in direct communication with themagnetron. An automated control system, controlled by a feedback loop,may be used to advance the tubes into the waveguide and towards thespring-like assembly 1604 and the die cavity 1608. In addition, one ormore light sensors/optical sensors may be used to detect the plasma arcformation. The one or more light sensors may send a signal to a motioncontrol system to advance the tubes 1600. In addition, one or moretemperature sensors may be used to determine the appropriate time toadvance the tube 1600 into the die cavity 1608 and/or to remove the tube1600 from the die cavity 1608. Additional sensors may be used to detectmotion, temperature, light and/or 2.45 GHz energy. Also, in someembodiments, one or more timers may be used in the feedback loop.Although a magnetron is described with respect to the exemplaryembodiments, in some embodiments, another source of 2.45 GHz energy maybe used.

Referring now to FIGS. 18A-18B, in other embodiments, a tube or needle1800, made from stainless steel or any other metal, may be connected,either removably or crimped together, to a metal part 1804, for example,a copper part, to form the inductor. In some embodiments, the metal part1804 may be crimped to the needle (see FIG. 18A). The distance 1806 orgap between needle 1800 and the metal part 1804, together with theapplication of RF at 2.45 GHz, completes a resonant tank circuit and aplasma arc may be formed. This will heat the needle 1800. As describedabove, one or more sensors, for example, but not limited to, opticaland/or temperature, may be used to provide feedback to a control loopand/or processor, to control the duration of the heating of the metalneedle 1800.

Referring now to FIG. 18B, the methods described above may be used invarious processes and method of manufacture, where controlled heating ofa metal or other material surface is desired. For example, a the metalpart 1.802 could take on any form, and as an example, could be aspring-like assembly as discussed above with respect to FIGS. 16A-16C.The needle 1800 may approach the metal part 1802, completing theresonant tank circuit. Once a plasma arc is formed, at an appropriatetime, for example, as the plasma arc diminishes (again, one or moresensors and/or timers, as discussed above, may be used to determine whenthe plasma arc forms and diminishes) the needle 1800 may advance towardsa contact, which mayh be a plastic part 1804, which may be any object orcontact made from plastic, including, but not limited to, a bag and/ortube, and the plastic may be any type of plastic, including, but notlimited to, PVC, PTFE and/or polyurathane. In some embodiments, thecontact may not be plastic. As the arc diminishes, while the needle 1800is being pushed into the plastic part 1804, the plastic part 1804 maymelt and then cool about the needle 1800. This process may produce asterile connection between a plastic part 1804 and a needle 1800.

Referring now to FIGS. 19A and 19B, in some embodiments, the catheterand introduction needle assembly may include a relief feature in theneedle to reduce the effect of the transition between the needle keepand the catheter tip. As shown in FIG. 19A, the needle 1900, having aneedle hole or opening 1904 includes a catheter 1902 about the needle1900. The catheter and needle assembly embodiment is described in moredetail above. However, this may provide a discontinuous profile at thetransition from the needle 1900 keel to the catheter 1902 tip. Referringnow to FIG. 19B, in some embodiments, a relief feature 1906 may beintroduced into the needle 1900. The relief feature 1900 may beintroduced using one or more of, but not limited to, the followingmethods: machining, grinding, forging, indented, and/or etched. In someembodiments, the relief feature 1906 may smooth the transition fromneedle 1900 to catheter 1902 while not prohibiting the catheter 1902 toslide forward off of the introduction needle 1900 at insertion. Althoughone embodiment of the relief is shown and described herein, othershapes, sizes and embodiments are considered and may vary from thatwhich is described herein.

While the principles of the invention have been described herein, it isto be understood by those skilled in the art that this description ismade only by way of example and not as a limitation as to the scope ofthe invention. Other embodiments are contemplated within the scope ofthe present invention in addition to the exemplary embodiments shown anddescribed herein. Modifications and substitutions by one of ordinaryskill in the art are considered to be within the scope of the presentinvention.

1. An insertion device comprising: a base portion; a top portionslidably connected to the base portion; an introduction needle; acatheter in slidable relation to the introduction needle; and asubstantially cylindrical flash chamber, the flash chamber having aninlet in fluid communication with the introduction needle; wherein theflash chamber is connected to the base portion, and wherein the topportion slidably engages with the flash chamber, and wherein thecatheter and the top portion slidably advance with respect to theintroduction needle and the base portion.
 2. The insertion device ofclaim 1, wherein the flash chamber further comprising an insert.
 3. Theinsertion device of claim 2, wherein the insert is a cylindrical insert.4. The insertion device of claim 2, wherein the insert comprising acolor contrasting to the color of a flash fluid.
 5. The insertion deviceof claim 2, wherein the insert comprising a material having wickingproperties.
 6. The insertion device of claim 5, wherein the wickingmaterial further comprising an assay test strip wherein the assay teststrip indicates the presence of one or more indicators in a fluid. 7.The insertion device of claim 1, wherein the flash chamber furthercomprising a filter.
 8. The insertion device of claim 7 wherein filtercomprising a membrane material.
 9. The insertion device of claim 1,wherein the flash chamber further comprising an expandable membrane influid communication with the introduction needle.
 10. The insertiondevice of claim 1 further comprising a needle guard removably connectedto the base portion.
 11. The insertion device of claim 1 wherein the topportion further comprising an opening to at least a portion of the flashchamber whereby the flash chamber may be viewed.
 12. The insertiondevice of claim 1, further comprising: a locking mechanism, wherein asthe top portion advances with respect to the base portion, the lockingmechanism moves from an unlocked position to a locked position, wherebyin the locked position, the top portion is positioned about the needle.13. The insertion device of claim 1, further comprising: a lockingmechanism having a first end and a second end, the locking mechanismlocated on the base portion; and a clip connected to the top portion,wherein the clip adapted to accommodate and control the lockingmechanism and wherein the clip slidably engages the locking mechanism,wherein as the top portion slidably advances with respect to the baseportion, the clip slidably advances from the first end of the lockingmechanism to the second end of the mechanism, whereby the lockingmechanism moves from an unlocked to a locked position and whereby in thelocked position, the top portion is positioned about the needle.
 14. Theinsertion device of claim 1, wherein the catheter further comprising: adistal end comprising a non-perpendicular angle to the axis of thecatheter and an underside conforming to a keel of the introductionneedle.
 15. An insertion device comprising: a base portion; a topportion slidably connected to the base portion; a substantiallycylindrical flash chamber, the flash chamber having an inlet and adaptedfor connection to an introduction needle, wherein the top portionslidably engages with the flash chamber; and a locking mechanism,wherein as the top portion advances with respect to the base portion,the locking mechanism moves from an unlocked position to a lockedposition.
 16. The insertion device of claim 15, wherein the flashchamber further comprising an insert.
 17. The insertion device of claim15, wherein the insert is a cylindrical insert.
 18. A method comprising:generating 2.45 GHz Radio Frequency energy using a magnetron; moving aneedle towards an object and a contact; maintaining a connection betweenthe needle and the contact; generating a plasma arc; and moving theneedle into contact with the object.
 19. The method of claim 18, furthercomprising moving the needle into contact with a die cavity for apredetermined amount of time and removing the needle from the diecavity.
 20. The method of claim 18, further comprising: moving theneedle into contact with a plastic tube; melting the plastic tube; andcooling the plastic tube wherein the plastic tube forms a seal about theneedle.